Regulatory Watch - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Regulatory Watch

Harmonizing Marketing Approval of Generic Drugs in Europe

October 2, 2014

Pharmaceutical Technology

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

Biopharma Manufacturers Respond to Ebola Crisis

October 2, 2014

Pharmaceutical Technology

Demand for new therapies and vaccines spotlights production challenges.

Data Integrity Key to GMP Compliance

September 2, 2014

Pharmaceutical Technology

FDA demands accurate manufacturing and test information to ensure product quality.

Extending the Scope of Pharmacovigilance Comes at a Price

September 2, 2014

Pharmaceutical Technology

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Changes and Challenges for Generic Drugs

August 2, 2014

Pharmaceutical Technology

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Industry Seeks Clearer Standards for Track and Trace

July 2, 2014

Pharmaceutical Technology

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Global Expansion Shapes Drug Oversight

June 2, 2014

Pharmaceutical Technology

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Regulating the Environmental Impact of Pharmaceuticals

June 2, 2014

Pharmaceutical Technology

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

Demand for New Vaccines Spurs Innovation

May 2, 2014

Pharmaceutical Technology

New formulations and expanded vaccine production are encouraged.

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What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
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Finance development of drugs to treat/prevent disease.
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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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